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Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke

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ClinicalTrials.gov Identifier: NCT03760016
Recruitment Status : Not yet recruiting
First Posted : November 30, 2018
Last Update Posted : November 30, 2018
Sponsor:
Collaborators:
University of Delaware
University of Kansas Medical Center
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Pierce Boyne, University of Cincinnati

Brief Summary:
The objective of this study is to determine the optimal training intensity and the minimum training duration needed to maximize immediate improvements in walking capacity in chronic stroke. A single-blind, phase II, 3-site randomized controlled trial has been planned. Fifty persons >6 months post stroke will randomize to either moderate-intensity aerobic locomotor training or high-intensity interval locomotor training; each for 45 minutes, 3x/week for up to 36 total sessions over approximately 12 weeks. Clinical measures of walking function, aerobic fitness, daily walking activity and quality of life will be assessed at baseline (PRE) and after 4, 8 and 12 weeks of training (POST-4WK, POST-8WK, POST-12WK).

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Moderate-Intensity Aerobic Training Behavioral: High-Intensity Interval Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke
Estimated Study Start Date : December 3, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Moderate-Intensity Aerobic Training Behavioral: Moderate-Intensity Aerobic Training
Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.

Experimental: High-Intensity Interval Training Behavioral: High-Intensity Interval Training
Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.




Primary Outcome Measures :
  1. Six-Minute Walk Test Distance [ Time Frame: 4 weeks ]
    Total distance walked in 6 minutes in meters

  2. Six-Minute Walk Test Distance [ Time Frame: up to 12 weeks ]
    Total distance walked in 6 minutes in meters


Secondary Outcome Measures :
  1. Comfortable Gait Speed [ Time Frame: 4 ,8, 12 weeks ]
    From 10-meter walk test, in meters per second

  2. Fast Gait Speed [ Time Frame: 4 ,8, 12 weeks ]
    From 10-meter walk test, in meters per second

  3. Aerobic Fitness [ Time Frame: 4 ,8, 12 weeks ]
    Oxygen consumption rate at ventilatory threshold during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  4. Exercise Capacity [ Time Frame: 4 ,8, 12 weeks ]
    Time to exhaustion during treadmill graded exercise test, recorded in minutes

  5. VO2-Peak [ Time Frame: 4 ,8, 12 weeks ]
    Peak oxygen consumption rate during treadmill graded exercise test, in milliliters per kilogram body mass per minute

  6. Metabolic Cost of Gait [ Time Frame: 4 ,8, 12 weeks ]
    Oxygen consumption rate relative to speed during treadmill graded exercise test, in milliliters per kilogram body mass per meter

  7. Daily Walking Activity [ Time Frame: 4 ,8, 12 weeks ]
    Mean daily step count recorded with activity monitor, recorded as steps per day

  8. EuroQol 5D-5L (EQ-5D-5L) [ Time Frame: 4 ,8, 12 weeks ]
    A 6-item questionnaire about quality of life, including: mobility, self-care, usual activities, pain/discomfort, anxiety/depression and overall health. Each item is scored from 1 to 5, where lower scores indicate greater quality of life. A total score will be calculated by averaging the scores for each item.

  9. Activities-specific Balance Confidence Scale [ Time Frame: 4 ,8, 12 weeks ]
    A 16-item questionnaire that asks participants to rate their balance confidence during everyday tasks, as a percentage from 0-100%, where higher scores indicate greater balance self-efficacy. A total score will be calculated by averaging the scores for each item.

  10. PROMIS-Fatigue Scale [ Time Frame: 4 ,8, 12 weeks ]
    An 8-item self-report questionnaire about symptoms of fatigue. Each item is rated from 1-5, where higher scores indicate greater fatigue. A total score will be calculated by averaging the scores for each item.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40-80 years at time of consenting
  2. Single stroke for which participant sought treatment, 6 months to 5 years prior to consent date
  3. Walking speed <1.0 m/s on the 10-meter walk test
  4. Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
  5. Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
  6. Stable cardiovascular condition (AHA class B, allowing for aerobic capacity <6 METs)
  7. Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions

Exclusion Criteria:

  1. Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out)
  2. Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
  3. Hospitalization for cardiac or pulmonary disease within past 3 months
  4. Implanted pacemaker or defibrillator
  5. Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
  6. Severe lower limb spasticity (Ashworth >2)
  7. Recent history (<3 months) of illicit drug or alcohol abuse or significant mental illness
  8. Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
  9. Currently participating in physical therapy or another interventional study
  10. Recent botulinum toxin injection to the paretic lower limb (<3 months) or planning to have lower limb botulinum toxin injection in the next 4 months
  11. Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
  12. Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
  13. Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
  14. Pregnancy
  15. Previous exposure to fast treadmill walking (>3 cumulative hours) during clinical or research therapy in the past year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760016


Contacts
Contact: Sarah Doren (513) 558-7487 strokerecovery@uc.edu

Locations
United States, Delaware
University of Delaware Not yet recruiting
Newark, Delaware, United States, 19713
Contact: Jane Diehl    302-831-4616    diehlj@udel.edu   
Principal Investigator: Darcy Reisman, PT, PhD         
United States, Kansas
University of Kansas Medical Center Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Jaimie Ward    913-588-2697    reachlab@kumc.edu   
Principal Investigator: Sandra Billinger, PT, PhD         
United States, Ohio
University of Cincinnati Not yet recruiting
Cincinnati, Ohio, United States, 45267
Contact: Sarah Doren    513-558-7487    strokerecovery@uc.edu   
Principal Investigator: Pierce Boyne, DPT, PhD         
Sponsors and Collaborators
University of Cincinnati
University of Delaware
University of Kansas Medical Center
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Pierce Boyne, DPT, PhD University of Cincinnati

Responsible Party: Pierce Boyne, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03760016     History of Changes
Other Study ID Numbers: 2017-5325
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to deposit the final, de-identified dataset and data documentation into a secure data archive
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be deposited after the primary manuscript from this study is accepted for publication and will likely remain available indefinitely.
Access Criteria: Will be determined by the data archive selected.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pierce Boyne, University of Cincinnati:
Rehabilitation
Locomotion
Aerobic
Intensity
Dosing

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases